Effectiveness of Stereotactic RadioTherapy in Solid Primary Inoperable and Oligometastatic Cancer

Radiotherapy Clinical Trial

— ESRTSPIOC  

Official title:

Study of Effectiveness of Stereotactic Body RadioTherapy and Stereotactic RadioSurgery in Solid Primary Inoperable and Oligometastatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03461822
• Other study ID #: MOM-0005
• Status: Recruiting
• Phase: N/A
• First received: February 20, 2018
• Last updated: March 5, 2018
• Start date: March 2013
• Est. completion date: January 2020

Study information

• Verified date: March 2018
• Source: The National Center of Oncology, Azerbaijan
• Contact: Azer Aliyev, PhD
• Phone: +994504054025
• Email: a.aliyev[@]yahoo.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to development of more effective treatment tactics of the stereotactic radiotherapy and radiosurgery alone and together with classic radiation therapy in primary inoperabel solid tumors and oligometastastatic cancer.

Description:

Despite the fact that of many investigations in the world clinical researches, the SRT of primary-inoperabel and metastatic solid tumors combined with conventional and conformal radiation therapy methods the possibility of the sequences, the optimal fractions of the regimes and doses which determines normal tissues toxic manifestations, implementation of prevention, have not been solved yet.

The conducted research works to study quality of life for improving the social status of patients with primary-inoperable and metastatic solid tumors, is not fully resolved.

Thus, preparing of highly effective treatment tactics in primary-inoperable and metastatic solid tumors, is one of the most important problems of modern clinical oncology and this fact gives grounds to carry out the planned research work.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed primary-inoperable solid tumors or oligometastatic cancer.

• Acceptance of patient by surgeon as non-operabel or refusing of surgery.

• No more than 4 metastatic foci in irradiated organ.

• Karnofsky scale more than 60.

• Age =18 years.

• Estimated duration of life >3 months.

• Hemoglobin = 8 g/dl.

• Absolute neutrophil count at least 1,500/mm^3.

• Platelet count at least 70,000/mm^3.

• Bilirubin no greater than 1.5 times normal.

• SGOT and SGPT no greater than 3 times normal.

• Creatinine less than 1.5 mg/dL. PT-INR/APTT less than 1.5.

• Last patients data no older than 1 month.

• No prior radiotherapy of same location.

• Prior chemottherapy more than 2 weeks ago.

Exclusion Criteria:

• Progression of primary site of metastatic cancer.

• Pregnancy or Breast-Feeding.

• Decompensated concomitant diseases.

Related Conditions & MeSH terms

• Radiotherapy

Locations

Country	Name	City	State
Azerbaijan	National Center of Oncology	Baku

Sponsors (1)

Lead Sponsor	Collaborator
The National Center of Oncology, Azerbaijan

Country where clinical trial is conducted

Azerbaijan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse Rate (local and/or distant)	clinical-instrumental or laboratory signs of local and/or distant recurrences of previously diagnosed oncological diaseases	5 years
Primary	Number of Deaths Due to Any Cause	Deaths due to any complications or progression of previously diagnosed oncological diaseases	5 years
Secondary	Incidence of acute toxicity	Number of adverse effects of irradiation observed in the patients within 3 months from the begginning of the treatment, measured by CTCAE 4.03 and/or EORTC/RTOG scales.	Up to 90 days after completion of radiation therapy
Secondary	Incidence of late toxicity	Number of adverse effects of irradiation observed in the patients after 3 months from the begginning of the treatment, measured by LENT SOMA scale.	Up to 2 years after completion of radiation therapy